Syngene is seeking a seasoned professional to manage its GCP quality function at THSTI Faridabad, Haryana on behalf of Syngene GCP Quality Organisation. He/she is responsible for building and scaling Quality Management Systems implementation programs and developing Quality assurance systems and implement QA oversight for clinical First-In Human (FIH) / Phase I studies and related activities.
Syngene International Ltd – GCP QA Auditor Vacancy
- Post: GCP QA Auditor (Clinical) – GCP QA Sr. Manager Clinical
- Department: GCP Quality, Syngene International Ltd
- Location: Translational Health Science and Technology Institute (THSTI) – Faridabad, Haryana, India
- Last Date to Apply: 23rd September 2026
- Apply Link: careers.syngeneintl.com/job/Bangalore-GCP-QA-Auditor-KA-560100/1367163866
Core Purpose of the Role
The GCP QA Sr.Manager-Clinical is responsible for managing the GCP QA audit management and auditors team and to perform the study-based audits, process audits, clinical and safety database audits, and assess the systems and practices for improving the GCP Quality System practices independently and shall consult with GCP Quality Head as required by Syngene International Ltd, Corporate Quality Policies.
This role is pivotal in quality and compliance oversight on clinical operations at the THSTI clinical research facility with the latest skills and knowledge to meet evolving client expectations and national and international regulatory standards.
Role Accountabilities
- Schedule, conduct and/or manage resources, for GCP QA audits for clinical FIH / Phase I / Bioequivalence studies, Clinical data management operations at THSTI facility
- Develop risk-based audit plan focusing on ethical conduct, safety & medical care of subjects, adherence to protocols, GCP requirements
- Provide oversight of GCP QA auditors to develop specific audit plans, review audit reports, CAPA adequacy
- Collaborate with clinical operations team in follow-up to external audits to ensure resolution of audit findings
- Collaborate in lessons learned debrief to identify continuous improvement
- Perform onsite / remote vendor audits and provide follow-up
- Lead/assist with investigations of misconduct, serious GCP breach and other noncompliance issues
- Perform / Oversee RCA and CAPA process
- Perform / Oversee internal process audits, due diligence, system audits, TMF audits, 21CFR Part 11 audits
- Maintain and report GCP QA team activity metrics, study quality metrics and trends
- Assist GCP QA HOD/management in readiness and hosting of regulatory agency inspections
Mandatory Expectation – Syngene Safety Guidelines
- Overall adherence to safe practices and procedures
- Contributing to development of procedures ensuring safe operations and compliance to integrity & quality standards
- Driving EHS mindset and operational discipline
- Ensure mandatory trainings related to data integrity, health, safety completed on time
- Compliance to Syngene’s quality standards at all times
Education & Skills
- Education: M.Pharm in Pharmacology Or QA / M.Sc. or M.Tech in Basic Medical Sciences / Life Sciences / Biotechnology
- Skills: Performing and managing QA audits in GCP environment
- Sound technical knowledge in BE / BA / Phase I studies / Clinical research / Drug development / Basic medical sciences and pharmacology
- Thorough knowledge in regulatory guidelines – ICH, USFDA, EMA, MHRA governing clinical development
- Strategic thinking and goal oriented with demonstrated good judgment
Syngene Values
Excellence, Integrity, Professionalism
How To Apply
APPLY FOR GCP QA AUDITOR CLINICAL >>
Last Date: 23rd Sep 2026
Official Website: https://www.syngeneintl.com/
Tags: Syngene GCP QA Auditor Job Faridabad 2026, THSTI Faridabad Haryana Clinical QA Jobs, MPharm MSc MTech Pharmacology Life Sciences Jobs, Syngene Careers GCP Quality Phase I FIH Bioequivalence, 23rd Sep 2026 Last Date
